The document provides information on agrochemical regulatory compliance and registration processes in several Southeast Asian countries, including Indonesia, Philippines, and Vietnam. It discusses the agriculture sectors and key crops in each country. For registration, it outlines the requirements and procedures, which typically involve submitting dossier documents, samples for testing, and fees to the respective regulatory authorities. Quality testing and efficacy testing are usually required to be conducted locally. The process often takes 12-18 months to complete and registrations must be renewed periodically. Household pesticides also have separate registration categories and processes in some countries.
The document summarizes the main revisions to China's Pesticide Management Regulation. Some key points:
- The regulation was revised in 2017 to better regulate the pesticide industry and address issues. It covers pesticide registration, production, use, and supervision.
- Revisions strengthen the management system, registration process, and oversight of production and use. Pesticide registration trials must now be done by approved entities to ensure data quality.
- Other changes include implementing registration renewal every 5 years, prohibiting temporary registration, and establishing a monitoring program to re-evaluate registered pesticides.
- The revisions aim to streamline administration, promote innovation, and regulate the industry according to international standards and practices.
ASEAN was established in 1967 by 5 countries and has since expanded to include 10 member countries. Singapore regulates pharmaceutical products under the Medicines Act and Health Products Act to ensure safety, quality and efficacy. The regulatory process for medicines involves submitting an application to the Health Sciences Authority, which evaluates the application and issues a regulatory decision of approval, approvable, non-approvable, or rejection.
It includes information about regulatory bodies, role of drug Regulatory professional, countries with their regulatory bodies, intellectual property rights, terminologies related to DRA, drug approval process, event regarding lack of Drug regulatory affairs
Marketing Authorization procedures in developed and developing countriesAkshay Saxena
This document provides an overview of marketing authorization procedures for pharmaceutical products in developing and developed countries. It discusses the regulatory bodies and approval processes in key markets like the EU, US, Canada, Japan, Brazil, Russia, India, and several ASEAN countries. The central topics covered include the Common Technical Document dossier format, ICH guidelines, variations to existing approvals, and timelines and fees for obtaining marketing authorization in different jurisdictions. The document aims to help pharmaceutical companies understand the requirements for marketing medicines internationally and comply with health regulations in various countries.
1) The document discusses guidelines for re-evaluating and managing maximum residue limits (MRLs) of pesticides and veterinary drugs in food in Korea.
2) It outlines the process for re-evaluating pesticides MRLs, deleting pesticides that are not registered domestically, and adopting MRLs for imported foods.
3) It also provides questions and answers to clarify the guidelines, such as the process for establishing new MRLs, data submission requirements, and timelines.
The document summarizes the main revisions to China's Pesticide Management Regulation. Some key points:
- The regulation was revised in 2017 to better regulate the pesticide industry and address issues. It covers pesticide registration, production, use, and supervision.
- Revisions strengthen the management system, registration process, and oversight of production and use. Pesticide registration trials must now be done by approved entities to ensure data quality.
- Other changes include implementing registration renewal every 5 years, prohibiting temporary registration, and establishing a monitoring program to re-evaluate registered pesticides.
- The revisions aim to streamline administration, promote innovation, and regulate the industry according to international standards and practices.
ASEAN was established in 1967 by 5 countries and has since expanded to include 10 member countries. Singapore regulates pharmaceutical products under the Medicines Act and Health Products Act to ensure safety, quality and efficacy. The regulatory process for medicines involves submitting an application to the Health Sciences Authority, which evaluates the application and issues a regulatory decision of approval, approvable, non-approvable, or rejection.
It includes information about regulatory bodies, role of drug Regulatory professional, countries with their regulatory bodies, intellectual property rights, terminologies related to DRA, drug approval process, event regarding lack of Drug regulatory affairs
Marketing Authorization procedures in developed and developing countriesAkshay Saxena
This document provides an overview of marketing authorization procedures for pharmaceutical products in developing and developed countries. It discusses the regulatory bodies and approval processes in key markets like the EU, US, Canada, Japan, Brazil, Russia, India, and several ASEAN countries. The central topics covered include the Common Technical Document dossier format, ICH guidelines, variations to existing approvals, and timelines and fees for obtaining marketing authorization in different jurisdictions. The document aims to help pharmaceutical companies understand the requirements for marketing medicines internationally and comply with health regulations in various countries.
1) The document discusses guidelines for re-evaluating and managing maximum residue limits (MRLs) of pesticides and veterinary drugs in food in Korea.
2) It outlines the process for re-evaluating pesticides MRLs, deleting pesticides that are not registered domestically, and adopting MRLs for imported foods.
3) It also provides questions and answers to clarify the guidelines, such as the process for establishing new MRLs, data submission requirements, and timelines.
This document discusses herbal cosmetics, including their definition, classification, economic aspects, regulations, and industries involved in production. Herbal cosmetics are defined as beauty products containing herbal ingredients that have physiological effects like skin healing. They are classified by dosage form (e.g. creams, oils) and body part (e.g. products for skin, hair, nails). The global herbal cosmetics market is valued at $1500 billion and growing. Major producers include China, India, Germany and France. Key Indian companies in this sector are Dabur, Emami, Patanjali, Himalaya and VLCC. The document also outlines licensing requirements, good manufacturing practices, and
Concept and principles of organic farming technologyNeeraj Pathak
Organic farming is based on principles of health, ecology, fairness and care. It prohibits synthetic pesticides, fertilizers, GMOs, antibiotics and growth hormones. India's National Programme for Organic Production established standards and certification systems for the organic sector. Organic agriculture in India has grown from 42,000 hectares in 2003-2004 to 1.78 million hectares in 2017-2018. Standards address crop plans, conversion periods, nutrient management, and pest and disease control primarily using on-farm resources. The government promotes organic farming through various schemes.
The document discusses the Organic Agriculture Production NC II course which consists of 4 competencies aimed at producing organic farm products. It covers basic skills like safety procedures and communication as well as core skills like raising organic chickens and producing organic fertilizer. The document also outlines Philippine standards and laws for organic agriculture which promote sustainable organic farming practices and food self-sufficiency. It describes the importance of organic certification for consumer protection and marketing and the types of certifying bodies and penalties for mislabeling products in the Philippines. Finally, it lists and describes various common hand tools used in organic farming.
Current status of the development, regulation and use of bio-pesticides in Ug...ILRI
Presented by Samuel Kyamanywa, Makerere University, at the Regional Experts Workshop on Development, Regulation and Use of Bio-pesticides in East Africa, Nairobi, Kenya, 22–23 May 2014
The document discusses the Food Safety and Standards Act (FSSA) 2006 and its impact on the food industry in India. It outlines some key issues with the previous multiplicity of food laws such as varied quality standards. It then summarizes some of the major features of the FSSA including provisions for licensing and registration, enforcement, adjudication, penalties, and regulations developed under the Act. Overall, the FSSA aims to establish a single reference point for all issues related to food safety and standards in India.
The document provides information on food supplement product registration requirements in Indonesia. It discusses the background and regulations of food supplements in Indonesia, requirements for company registration and food supplement product registration, including necessary documents and labeling. The registration process takes approximately 3-6 months and requires documents such as a letter of authorization, certificate of free sales, GMP certification and product analysis certificates.
The document provides information on Malaysia's drug approval system. It discusses the National Pharmaceutical Regulatory Agency (NPRA) which ensures the quality, safety and efficacy of medicines through registration and licensing. The registration process for new drug products, generics, biologics and other product types is outlined. Guidelines and requirements for registration include Good Manufacturing Practice standards and ASEAN Common Technical Dossiers. Alternative pathways like priority review, conditional registration and facilitated registration are available to expedite approval of certain products. Statistics on registered manufacturers, importers, wholesalers, products and notified cosmetics in Malaysia are also presented.
National Program for Organic Certification in India. NPOP is indian organic certification standard, It monitors the use of India Organic Logo by certified operations. STOCERT provides certification services in India
10.Global Perspective on Agrochemical Regulations - status and way forward.pdfJayaSharma632734
The document provides an overview of agrochemical regulations around the world, organized by region. For North America, it describes the key regulatory frameworks and agencies in the US and Canada. In the US, laws like FIFRA, FQPA, and ESA provide federal oversight of pesticide use, including requirements for assessing cumulative effects, vulnerable groups, and endangered species impacts. The EDSP screens for endocrine disruption potential. In Canada, PMRA reviews data for registration and adherence to OECD guidelines. Central and South American countries generally follow similar processes as the US, while the OIRSA promotes harmonization. Regulations in Australia, New Zealand, Japan, South Korea, and Taiwan also assess human health and environmental risks in line with
GMP Guidelines for Nutraceuticals - Indian And EuropeanVarshaJindaniya
This GMP Guidance Document covers the entire manufacturing process of Health Supplements/ Nutraceuticals in the form of Powders, Tablets, Capsules, Soft Gel Capsules and Liquids starting from procurement of raw materials to despatch of finished product.
Contact me: www.linkedin.com/in/varsha-jindaniya
This document discusses the SWOT analysis of Incepta Pharmaceuticals Ltd., a leading pharmaceutical company in Bangladesh. It identifies strengths such as a wide range of quality products and competitive pricing. Weaknesses include a reliance on imported raw materials. Opportunities include expanding exports and producing active pharmaceutical ingredients. Threats include increased competition from India and changes from TRIPS that could impact the local and export markets. The document also discusses challenges facing the pharmaceutical industry in Bangladesh.
Registration Process for Biostimulants in India.pptxNRTP Enterprises
Are you looking for registering biostimulant products in India? NRTP Enterprises provides Registration Process for Biostimulant in India for sustainability in agriculture and ultimately benefiting farmers.
CGMP is current good manufacturing practices followed for achieving good quality product which is effective and safe for patients. USFDA's motto is to protect the health of patients along with biologicals.
EMEA is supposed to take care of medicines for human use as veterinary use.
CDER & CBER are the main branches of USFDA which gives guidelines for drug & biologics.
This document discusses guidelines for safe pesticide use, including establishing maximum residue levels and acceptable daily intakes. It also addresses challenges with regulating the pesticide industry to prevent spurious products, and the importance of integrated pest management in controlling pests with minimal reliance on chemicals.
This document provides information on organic farming in India. It discusses that organic farming avoids synthetic inputs and relies on natural methods. It also outlines the national standards for organic crop production including requirements for seeds, fertilization, pest and disease management, and soil and water conservation. The certification process in India involves accredited certification agencies that inspect farms and issue certification according to standards set by the National Programme for Organic Production.
This document outlines India's national pharmaceutical policy and the strengths of India's pharmaceutical industry. It discusses India's vision to enable the pharmaceutical industry to play a leading role globally and ensure availability of quality drugs domestically. It highlights key strengths like being the 3rd largest producer globally by volume, having a large skilled workforce and low production costs, and strong export market of $15 billion to over 200 countries. The policy aims to promote the industry through initiatives like increasing R&D and developing world-class research institutes. Stringent quality regulations and inspections ensure drugs meet domestic and international standards.
The document discusses pharmaceutical education and the pharmaceutical industry in India. It provides details on the different pharmacy education programs in India such as D.Pharm, B.Pharm, M.Pharm, Pharm.D, and their admission criteria and course durations. It also lists some of the top pharmacy colleges in India and concludes that model pharmacies should be operated by institutes to improve pharmacists' image and provide training. The document then summarizes key aspects of the large and growing pharmaceutical industry in India such as its global contribution, exports, and regulatory control.
The document discusses establishing an organic agriculture certification system in Pakistan. It outlines the following key points:
- The National Institute of Organic Agriculture will provide training on sustainable farming practices, research alternative farming methods, and develop organic certification standards in line with IFOAM.
- The certification system will involve training farmers, inspecting farms, and issuing certifications locally at first through technical working committees. For exports, farms will be referred to third-party certifiers.
- A national technical working group on organic certification is proposed, consisting of experts from the government, certification bodies, and NGOs to develop policies and regulations for the system.
- The goals are to promote organic farming, identify suitable crops
This document provides information about organic agriculture in India. It discusses key topics such as:
- Definitions and principles of organic agriculture according to IFOAM.
- Statistics on the percentage of area under organic farming in different countries worldwide, with Germany having the highest at 8.4%.
- National trends in India, including the total number of organic farmers and top states such as Madhya Pradesh and Himachal Pradesh.
- The need for and process of organic certification to assure consumers that products meet organic standards. This involves accreditation, standards, inspection and certification.
- National Standards for Organic Production in India for crops, livestock management, animal nutrition and prohibited substances.
ESPP presentation to EU Waste Water Network, 4th June 2024 “EU policies driving nutrient removal and recycling
and the revised UWWTD (Urban Waste Water Treatment Directive)”
More Related Content
Similar to 12.Agrochemical Compliance in South East Asia countries Vietnam, Indonesia, Philippines and Cambodia.pdf
This document discusses herbal cosmetics, including their definition, classification, economic aspects, regulations, and industries involved in production. Herbal cosmetics are defined as beauty products containing herbal ingredients that have physiological effects like skin healing. They are classified by dosage form (e.g. creams, oils) and body part (e.g. products for skin, hair, nails). The global herbal cosmetics market is valued at $1500 billion and growing. Major producers include China, India, Germany and France. Key Indian companies in this sector are Dabur, Emami, Patanjali, Himalaya and VLCC. The document also outlines licensing requirements, good manufacturing practices, and
Concept and principles of organic farming technologyNeeraj Pathak
Organic farming is based on principles of health, ecology, fairness and care. It prohibits synthetic pesticides, fertilizers, GMOs, antibiotics and growth hormones. India's National Programme for Organic Production established standards and certification systems for the organic sector. Organic agriculture in India has grown from 42,000 hectares in 2003-2004 to 1.78 million hectares in 2017-2018. Standards address crop plans, conversion periods, nutrient management, and pest and disease control primarily using on-farm resources. The government promotes organic farming through various schemes.
The document discusses the Organic Agriculture Production NC II course which consists of 4 competencies aimed at producing organic farm products. It covers basic skills like safety procedures and communication as well as core skills like raising organic chickens and producing organic fertilizer. The document also outlines Philippine standards and laws for organic agriculture which promote sustainable organic farming practices and food self-sufficiency. It describes the importance of organic certification for consumer protection and marketing and the types of certifying bodies and penalties for mislabeling products in the Philippines. Finally, it lists and describes various common hand tools used in organic farming.
Current status of the development, regulation and use of bio-pesticides in Ug...ILRI
Presented by Samuel Kyamanywa, Makerere University, at the Regional Experts Workshop on Development, Regulation and Use of Bio-pesticides in East Africa, Nairobi, Kenya, 22–23 May 2014
The document discusses the Food Safety and Standards Act (FSSA) 2006 and its impact on the food industry in India. It outlines some key issues with the previous multiplicity of food laws such as varied quality standards. It then summarizes some of the major features of the FSSA including provisions for licensing and registration, enforcement, adjudication, penalties, and regulations developed under the Act. Overall, the FSSA aims to establish a single reference point for all issues related to food safety and standards in India.
The document provides information on food supplement product registration requirements in Indonesia. It discusses the background and regulations of food supplements in Indonesia, requirements for company registration and food supplement product registration, including necessary documents and labeling. The registration process takes approximately 3-6 months and requires documents such as a letter of authorization, certificate of free sales, GMP certification and product analysis certificates.
The document provides information on Malaysia's drug approval system. It discusses the National Pharmaceutical Regulatory Agency (NPRA) which ensures the quality, safety and efficacy of medicines through registration and licensing. The registration process for new drug products, generics, biologics and other product types is outlined. Guidelines and requirements for registration include Good Manufacturing Practice standards and ASEAN Common Technical Dossiers. Alternative pathways like priority review, conditional registration and facilitated registration are available to expedite approval of certain products. Statistics on registered manufacturers, importers, wholesalers, products and notified cosmetics in Malaysia are also presented.
National Program for Organic Certification in India. NPOP is indian organic certification standard, It monitors the use of India Organic Logo by certified operations. STOCERT provides certification services in India
10.Global Perspective on Agrochemical Regulations - status and way forward.pdfJayaSharma632734
The document provides an overview of agrochemical regulations around the world, organized by region. For North America, it describes the key regulatory frameworks and agencies in the US and Canada. In the US, laws like FIFRA, FQPA, and ESA provide federal oversight of pesticide use, including requirements for assessing cumulative effects, vulnerable groups, and endangered species impacts. The EDSP screens for endocrine disruption potential. In Canada, PMRA reviews data for registration and adherence to OECD guidelines. Central and South American countries generally follow similar processes as the US, while the OIRSA promotes harmonization. Regulations in Australia, New Zealand, Japan, South Korea, and Taiwan also assess human health and environmental risks in line with
GMP Guidelines for Nutraceuticals - Indian And EuropeanVarshaJindaniya
This GMP Guidance Document covers the entire manufacturing process of Health Supplements/ Nutraceuticals in the form of Powders, Tablets, Capsules, Soft Gel Capsules and Liquids starting from procurement of raw materials to despatch of finished product.
Contact me: www.linkedin.com/in/varsha-jindaniya
This document discusses the SWOT analysis of Incepta Pharmaceuticals Ltd., a leading pharmaceutical company in Bangladesh. It identifies strengths such as a wide range of quality products and competitive pricing. Weaknesses include a reliance on imported raw materials. Opportunities include expanding exports and producing active pharmaceutical ingredients. Threats include increased competition from India and changes from TRIPS that could impact the local and export markets. The document also discusses challenges facing the pharmaceutical industry in Bangladesh.
Registration Process for Biostimulants in India.pptxNRTP Enterprises
Are you looking for registering biostimulant products in India? NRTP Enterprises provides Registration Process for Biostimulant in India for sustainability in agriculture and ultimately benefiting farmers.
CGMP is current good manufacturing practices followed for achieving good quality product which is effective and safe for patients. USFDA's motto is to protect the health of patients along with biologicals.
EMEA is supposed to take care of medicines for human use as veterinary use.
CDER & CBER are the main branches of USFDA which gives guidelines for drug & biologics.
This document discusses guidelines for safe pesticide use, including establishing maximum residue levels and acceptable daily intakes. It also addresses challenges with regulating the pesticide industry to prevent spurious products, and the importance of integrated pest management in controlling pests with minimal reliance on chemicals.
This document provides information on organic farming in India. It discusses that organic farming avoids synthetic inputs and relies on natural methods. It also outlines the national standards for organic crop production including requirements for seeds, fertilization, pest and disease management, and soil and water conservation. The certification process in India involves accredited certification agencies that inspect farms and issue certification according to standards set by the National Programme for Organic Production.
This document outlines India's national pharmaceutical policy and the strengths of India's pharmaceutical industry. It discusses India's vision to enable the pharmaceutical industry to play a leading role globally and ensure availability of quality drugs domestically. It highlights key strengths like being the 3rd largest producer globally by volume, having a large skilled workforce and low production costs, and strong export market of $15 billion to over 200 countries. The policy aims to promote the industry through initiatives like increasing R&D and developing world-class research institutes. Stringent quality regulations and inspections ensure drugs meet domestic and international standards.
The document discusses pharmaceutical education and the pharmaceutical industry in India. It provides details on the different pharmacy education programs in India such as D.Pharm, B.Pharm, M.Pharm, Pharm.D, and their admission criteria and course durations. It also lists some of the top pharmacy colleges in India and concludes that model pharmacies should be operated by institutes to improve pharmacists' image and provide training. The document then summarizes key aspects of the large and growing pharmaceutical industry in India such as its global contribution, exports, and regulatory control.
The document discusses establishing an organic agriculture certification system in Pakistan. It outlines the following key points:
- The National Institute of Organic Agriculture will provide training on sustainable farming practices, research alternative farming methods, and develop organic certification standards in line with IFOAM.
- The certification system will involve training farmers, inspecting farms, and issuing certifications locally at first through technical working committees. For exports, farms will be referred to third-party certifiers.
- A national technical working group on organic certification is proposed, consisting of experts from the government, certification bodies, and NGOs to develop policies and regulations for the system.
- The goals are to promote organic farming, identify suitable crops
This document provides information about organic agriculture in India. It discusses key topics such as:
- Definitions and principles of organic agriculture according to IFOAM.
- Statistics on the percentage of area under organic farming in different countries worldwide, with Germany having the highest at 8.4%.
- National trends in India, including the total number of organic farmers and top states such as Madhya Pradesh and Himachal Pradesh.
- The need for and process of organic certification to assure consumers that products meet organic standards. This involves accreditation, standards, inspection and certification.
- National Standards for Organic Production in India for crops, livestock management, animal nutrition and prohibited substances.
Similar to 12.Agrochemical Compliance in South East Asia countries Vietnam, Indonesia, Philippines and Cambodia.pdf (20)
ESPP presentation to EU Waste Water Network, 4th June 2024 “EU policies driving nutrient removal and recycling
and the revised UWWTD (Urban Waste Water Treatment Directive)”
Unlocking the mysteries of reproduction: Exploring fecundity and gonadosomati...AbdullaAlAsif1
The pygmy halfbeak Dermogenys colletei, is known for its viviparous nature, this presents an intriguing case of relatively low fecundity, raising questions about potential compensatory reproductive strategies employed by this species. Our study delves into the examination of fecundity and the Gonadosomatic Index (GSI) in the Pygmy Halfbeak, D. colletei (Meisner, 2001), an intriguing viviparous fish indigenous to Sarawak, Borneo. We hypothesize that the Pygmy halfbeak, D. colletei, may exhibit unique reproductive adaptations to offset its low fecundity, thus enhancing its survival and fitness. To address this, we conducted a comprehensive study utilizing 28 mature female specimens of D. colletei, carefully measuring fecundity and GSI to shed light on the reproductive adaptations of this species. Our findings reveal that D. colletei indeed exhibits low fecundity, with a mean of 16.76 ± 2.01, and a mean GSI of 12.83 ± 1.27, providing crucial insights into the reproductive mechanisms at play in this species. These results underscore the existence of unique reproductive strategies in D. colletei, enabling its adaptation and persistence in Borneo's diverse aquatic ecosystems, and call for further ecological research to elucidate these mechanisms. This study lends to a better understanding of viviparous fish in Borneo and contributes to the broader field of aquatic ecology, enhancing our knowledge of species adaptations to unique ecological challenges.
Remote Sensing and Computational, Evolutionary, Supercomputing, and Intellige...University of Maribor
Slides from talk:
Aleš Zamuda: Remote Sensing and Computational, Evolutionary, Supercomputing, and Intelligent Systems.
11th International Conference on Electrical, Electronics and Computer Engineering (IcETRAN), Niš, 3-6 June 2024
Inter-Society Networking Panel GRSS/MTT-S/CIS Panel Session: Promoting Connection and Cooperation
https://www.etran.rs/2024/en/home-english/
Phenomics assisted breeding in crop improvementIshaGoswami9
As the population is increasing and will reach about 9 billion upto 2050. Also due to climate change, it is difficult to meet the food requirement of such a large population. Facing the challenges presented by resource shortages, climate
change, and increasing global population, crop yield and quality need to be improved in a sustainable way over the coming decades. Genetic improvement by breeding is the best way to increase crop productivity. With the rapid progression of functional
genomics, an increasing number of crop genomes have been sequenced and dozens of genes influencing key agronomic traits have been identified. However, current genome sequence information has not been adequately exploited for understanding
the complex characteristics of multiple gene, owing to a lack of crop phenotypic data. Efficient, automatic, and accurate technologies and platforms that can capture phenotypic data that can
be linked to genomics information for crop improvement at all growth stages have become as important as genotyping. Thus,
high-throughput phenotyping has become the major bottleneck restricting crop breeding. Plant phenomics has been defined as the high-throughput, accurate acquisition and analysis of multi-dimensional phenotypes
during crop growing stages at the organism level, including the cell, tissue, organ, individual plant, plot, and field levels. With the rapid development of novel sensors, imaging technology,
and analysis methods, numerous infrastructure platforms have been developed for phenotyping.
EWOCS-I: The catalog of X-ray sources in Westerlund 1 from the Extended Weste...Sérgio Sacani
Context. With a mass exceeding several 104 M⊙ and a rich and dense population of massive stars, supermassive young star clusters
represent the most massive star-forming environment that is dominated by the feedback from massive stars and gravitational interactions
among stars.
Aims. In this paper we present the Extended Westerlund 1 and 2 Open Clusters Survey (EWOCS) project, which aims to investigate
the influence of the starburst environment on the formation of stars and planets, and on the evolution of both low and high mass stars.
The primary targets of this project are Westerlund 1 and 2, the closest supermassive star clusters to the Sun.
Methods. The project is based primarily on recent observations conducted with the Chandra and JWST observatories. Specifically,
the Chandra survey of Westerlund 1 consists of 36 new ACIS-I observations, nearly co-pointed, for a total exposure time of 1 Msec.
Additionally, we included 8 archival Chandra/ACIS-S observations. This paper presents the resulting catalog of X-ray sources within
and around Westerlund 1. Sources were detected by combining various existing methods, and photon extraction and source validation
were carried out using the ACIS-Extract software.
Results. The EWOCS X-ray catalog comprises 5963 validated sources out of the 9420 initially provided to ACIS-Extract, reaching a
photon flux threshold of approximately 2 × 10−8 photons cm−2
s
−1
. The X-ray sources exhibit a highly concentrated spatial distribution,
with 1075 sources located within the central 1 arcmin. We have successfully detected X-ray emissions from 126 out of the 166 known
massive stars of the cluster, and we have collected over 71 000 photons from the magnetar CXO J164710.20-455217.
Describing and Interpreting an Immersive Learning Case with the Immersion Cub...Leonel Morgado
Current descriptions of immersive learning cases are often difficult or impossible to compare. This is due to a myriad of different options on what details to include, which aspects are relevant, and on the descriptive approaches employed. Also, these aspects often combine very specific details with more general guidelines or indicate intents and rationales without clarifying their implementation. In this paper we provide a method to describe immersive learning cases that is structured to enable comparisons, yet flexible enough to allow researchers and practitioners to decide which aspects to include. This method leverages a taxonomy that classifies educational aspects at three levels (uses, practices, and strategies) and then utilizes two frameworks, the Immersive Learning Brain and the Immersion Cube, to enable a structured description and interpretation of immersive learning cases. The method is then demonstrated on a published immersive learning case on training for wind turbine maintenance using virtual reality. Applying the method results in a structured artifact, the Immersive Learning Case Sheet, that tags the case with its proximal uses, practices, and strategies, and refines the free text case description to ensure that matching details are included. This contribution is thus a case description method in support of future comparative research of immersive learning cases. We then discuss how the resulting description and interpretation can be leveraged to change immersion learning cases, by enriching them (considering low-effort changes or additions) or innovating (exploring more challenging avenues of transformation). The method holds significant promise to support better-grounded research in immersive learning.
When I was asked to give a companion lecture in support of ‘The Philosophy of Science’ (https://shorturl.at/4pUXz) I decided not to walk through the detail of the many methodologies in order of use. Instead, I chose to employ a long standing, and ongoing, scientific development as an exemplar. And so, I chose the ever evolving story of Thermodynamics as a scientific investigation at its best.
Conducted over a period of >200 years, Thermodynamics R&D, and application, benefitted from the highest levels of professionalism, collaboration, and technical thoroughness. New layers of application, methodology, and practice were made possible by the progressive advance of technology. In turn, this has seen measurement and modelling accuracy continually improved at a micro and macro level.
Perhaps most importantly, Thermodynamics rapidly became a primary tool in the advance of applied science/engineering/technology, spanning micro-tech, to aerospace and cosmology. I can think of no better a story to illustrate the breadth of scientific methodologies and applications at their best.
Or: Beyond linear.
Abstract: Equivariant neural networks are neural networks that incorporate symmetries. The nonlinear activation functions in these networks result in interesting nonlinear equivariant maps between simple representations, and motivate the key player of this talk: piecewise linear representation theory.
Disclaimer: No one is perfect, so please mind that there might be mistakes and typos.
dtubbenhauer@gmail.com
Corrected slides: dtubbenhauer.com/talks.html
Travis Hills' Endeavors in Minnesota: Fostering Environmental and Economic Pr...Travis Hills MN
Travis Hills of Minnesota developed a method to convert waste into high-value dry fertilizer, significantly enriching soil quality. By providing farmers with a valuable resource derived from waste, Travis Hills helps enhance farm profitability while promoting environmental stewardship. Travis Hills' sustainable practices lead to cost savings and increased revenue for farmers by improving resource efficiency and reducing waste.
2. Auxilife was incorporated
operational in June 2012.
in India November 2011 and became
Auxilife is a subsidiary of Global Product
Compliance (GPC) Europe AB, Sweden. Auxilife help agrochemical
companies for regulatory compliance globally and help companies for
product registration, understanding market, field trials, CRO collaboration
for studies and holistic overview of agrochemical regulatory compliance.
Experience Quality Support Confidentiality
Auxilife Elements
A-503, Speciality Business Center, Balewadi Road, Pune-411045, Maharashtra, India.
3. Auxilife Business Model
Support International
companies to register
their products in
India.
Support Indian companies
to register their products
outside India.
7. Introduction
• The agrochemicals’ industry is growing
• Needs for agrochemical regulations to reduce pesticides’ hazards
• In this webinar, the aim is to address registration requirements and procedures for
agrochemicals in Indonesia, Cambodia, Philippines, and Vietnam
• Key points to be covered:
• General reference to countries, and
• Agriculture, pesticides used
• Registration procedure including glimpses on household pesticides
9. Indonesia—Agriculture Overview
• The largest archipelago and island country and the fourth largest
populated country
• One of the largest bio diversified areas
• Agriculture is one of the key sectors, contributing approx. 15 % to
national GDP
• Main Agricultural Produces are Rice, corn, cassava, soybeans, peanuts,
Palm oil, tea, coffee, cacao, medicinal plants, spices, and rubber
• The major food crops by area of cultivation: rice
• Main Fruits grown: banana and mango
• Main Vegetables grown: potato, tomato, cassavaand onion.
10. Indonesia—Agrochemical Overview
• Pesticide consumption is one of the lowest in Indonesia (0.04 kg/ha). A lot
of spurious /substandard pesticides are present in the market
• A growth of ~ 9 % is predicted for agro chemicals annually.
• Herbicides dominate the market followed by fungicides &
insecticides Demand for insecticides are increasing with prolonged dry
seasons in the country.
• Liquid , granules and powder formulations are the major type of
formulations used with consumption of granule and powder formulations
dominating than of liquid products. Liquid formulations which are cheap
and easy to use are preferred.
• US, China, France, UK, Malaysia, Thailand and Philippines are the major
exporters of pesticides to Indonesia.
• India's export to Indonesia is only 3% of its total pesticide's exports.
11. REGISTRATION OF PESTICIDES
• Ministry of Agriculture is the responsible ministry.
• Pesticide Regulation No. 7. of 1973 is the original Decree. Ministry of
Agriculture Decree No. 434.1/Kpts/TP.270/7/2001:Pesticide Registration is
the current version.
• There are two types of pesticides with reference to registration.
Pesticides which can be registered and pesticides which cannot be
registered.
• Pesticides which cannot be registered are pesticides which are highly
toxic by oral, dermal or inhalation route and/or corrosive to skin and
mucous membrane and prohibited pesticides.
• Pesticides which can be registered are of two types- general pesticides
and restricted use pesticides.
12. • General pesticides are pesticides which can be handled without any
special training.
• Restricted pesticides are those pesticides which require special skill and
training to handle.
• Application for registration shall be submitted to Director General of
Agriculture under the Ministry of Agriculture accompanied by the
required data prescribed in the guidelines. Pesticide Sub Committee will
review the applications and submit its recommendation to Director
General of Agriculture.
• There are three types of registrations
• Trial use permission
• Provisional registration
• Full registration
• Trial use registration/permission
It is for establishing/verifying the efficacy of the product as claimed.
Director General will grant trial permission, within 14 days after
receiving recommendation from the pesticide sub committee.
13. • It is valid for 1 year and can be extended to 1 more year. No commercial
manufacturing or distribution is allowed during this period.
• Provisional registration
• It is for completing the submission of the pending data/fulfilling
additional data and is also valid for 1 year but can be extended to a
maximum period of 3 years.
Application
for Trials
Trial
Permission
from DG
Sample
submission
to DG
Quality
Analysis
Sample for
Trials to the
Institutes
14. • Trial results shall be submitted to the pesticides sub committee, and it will
review the results and submit its recommendation to the DG Agriculture.
DG will send its recommendationto the ministry within 90 days
• The Ministry of Agriculture will grant registration with such terms and
conditions which it may deem fit with regard to safety to the
environment and human health.
• As per the Decree No. 01 of 2019 of the Minister of Agriculture organic
fertilizers, biofertilizers and soil enhancers produced locally or imported,
are also to be registered
Trial Results
Pesticide Sub
Committee
DG
Agriculture
Ministry of
Agriculture
Registration
15. • Requirement for registrations are
• Quality testing based on the relevant Indonesian Standard (SNIs) as applicable. Minimum
Technical Requirements as prescribed by FAO, information on composition, impurities
present, physico-chemical properties, efficacy residue, toxicity to human and
environment, disposal, safety precautions etc.
• Household pesticides and Public health pesticides
• Are also registered by the ministry of Agriculture.
• Quality testing and efficacy testing are to be mandatorily done in Indonesia.
• Registration will take around 18 months to complete.
• Registration is valid for 5 years and can be renewed further if not banned.
19. Philippines—Agriculture Overview
• An archipelagic country situated in the western Pacific Ocean and
consistsof about 7,640 islands, covering 300,000 km2 area
• 3rd largest economy in the ASEAN. Economy is changing from agriculture
based to services and manufacturing based
• Major trading partners: the US, Japan, China, Singapore, South Korea, the
Netherlands, Hong Kong, Germany, Taiwan, and Thailand.
• Main agricultural crops: rice, corn, coconut,sugarcane, bananas,
pineapple, coffee, mangoes, tobacco, and abaca
• Other crops include peanut, cassava, camote, garlic, onion, cabbage, eggplant,
calamansi, rubber, and cotton
• Coconut oil & coconut products are the major export products along with Banana
and pineapple.
20. Philippines—Agrochemical Overview
• According to FAO statistics,Philippines pesticide market grew at
a rate of 11.6 % between 2011&2017
• Pesticides imported mainly from USA, China, Indonesia, India,
Malaysia, Thailand and Korea.
• Insecticides are the most imported category of pesticides
22. Philippines—Registration of pesticides
Registering authority
Fertilizer & Pesticide Authority of Ministry of Agriculture
Requirements for imported pesticides
Certificate Authorizing Importation of Pesticides (CAIPs) issued
by Fertilizer & Pesticides Authority (FPA)*
Requirements for importers
Licence to Operate (LTO)
23. Philippines—Registration requirements
• Prior to the issuance of CAIP, importing companies shall also hold a Certificate of
Product Registration (CPR)
• Companies or businesses registered as per the Philippine Law can only do
business and apply for registration of pesticide product/active ingredients may to
the FPA, Philippines.
• An application for registration of an active ingredient shall be submitted in P-012
and a formulated product in P022 (in duplicate)
along with data required to support the registration as specified in the
guidelines.
• Test reports shall comply with internationally accepted scientific practices, GLP’s
and test protocols.
24. Philippines—Registration requirements
• A summary of the data submitted and an applicant’s assessmentof how
these data support registration for the purpose, uses and directions for
use in the draft label
• Proof of registration in other countries
• Proposed label for Philippines
• An applicant shall submit 500 ml/g (as the case may be) of the sample of
the product to be registered along with 1g analytical grade of the active
ingredient(s) and 10g technical material to FPA
• Reviews of data done by other countries of international organizations, if
available.
• Registration fee
See https://fpa.da.gov.ph/index.php/information-resources/fees-and-
charges/fertilizer-pesticide-fees-and-charges
• Any authorization necessary to cite previously submitted data.
25. Experimental Use
Permit (EUP)
If experimental samples are
to be imported for the
registration of a pesticide, a
prior approved
Experimental Use Permit
(EUP) from FPA is required.
Documents required:
1) Completed application form
2) Technical data requirements
3) Application for a company
license as Importer-National
Distributor /End-user.
Philippines—Registration requirements for EUP
26. Philippines— Household Pesticides
• Registered by the Department of Health/FDA
• Both Household pesticides and their active ingredients are to be
registered with FDA.
• If the active ingredient is already registered with FPA and is valid while
applying for the registration of a formulation with FDA, then there is
no need of registration of the active ingredient again. FDA shall accept
FPA registration.
• If the formulation to be registered with FDA can also be used as
an agrochemical then the product shall be registered with both FPA
and FDA.
• Registration is valid for a period of maximum 5 years.
28. Vietnam—Agriculture Overview
• Vietnam is located at the Southeast Asia and is the world’s 15th most
populous country with a population over 96 million
• Agriculture and forestry accountedfor around 20% of Vietnam's GDP, in
which agriculture takes up about 14%
• Agriculture's share on economic output is declining in recent years
• Agricultural land in Vietnam is 27.3 million ha including forestry land.
Land holdings are fragmented with 90 % having less than 0.5 ha. And 25
% having 0.5 to 2.0 ha
• Major agriculture products: corn, sorghum, cassava, sweet potatoes, beans,
sugarcane, groundnut, soybeans, Rubber, fruits, and vegetables
• Industrial and export crops produced in Vietnam: coffee, tea, tobacco, pepper,
cashew and jute
29. Vietnam—Agrochemical Overview
• Most of the pesticide applications are in crops like cereals & grains, fruits &
vegetables, oilseeds & pulses, and others
• According to Ministry of Agriculture and Rural Development, Vietnam spent
around USD 1000 million on imported pesticides.
• Paddy field rice cultivation accountsfor about 50% of crop protection
demand in Vietnam.
• Most imported items are herbicides followed by
insecticides, fungicides and others including rodenticides, chemicals used
for drainage, timber preservatives, storage chemicals etc.
30. Vietnam—Registration of pesticides
Registering authority
Plant Protection Department (PPD) Ministry of Agriculture and Rural
Development
Eligible applicants
- Vietnam Citizens (legal/individuals) who manufacturing pesticides
- Permitted Foreign organizations and individual manufacturers
Required data
Including: data on Phys-chem, toxicity, environmental effects, efficacy and
residue
31. Vietnam—Registration process
Applicant
Plant Protection
Department (PPD)
Registered for
the first time
Approved
Minister of
Agriculture and Rural
Development
Submit application
with required data
Evaluate the
application
Issue the certificate
within six months
Efficacy trials are to
be conducted in
Vietnam
Rejected
Certificates of
registration valid for
5 years
recommend
Written reasons
for rejection
32. Vietnam—Household /Public Health
• Public Health products are to be registered with Health and Environmental
Agency (HEMA), Ministry of Health.
• Process of registration is not time consuming. Limited data is required for
registration.
• Testing of products in Vietnam is compulsory.
• Time required for approval is around 6 - 8 months for vector Control Products.
Products used in Vector Control Program shall be evaluated and recommended
by WHO.
• Chlorpyrifos ethyl, Hexythiazox, Fipronil, Beta-cyfluthrin and Cyfluthrin are
banned for Household & Public health use.
• Novaluron, Diflubenzuron, Pyriproxyfen, Temephos, Spinosad and Emamectin
benzoate are restricted for use.
34. Cambodia—Agriculture Overview
• Located in the southern portion of the Indochinese
Peninsula in Mainland Southeast Asia
• Per capita income is low compared to most of the neighbouring countries
• One of the fastest-growing economies in Asia
• Agriculture remains dominant economic sector, most rural households
depend on agriculture and its related subsectors
• Major crop is Rice. The principal commercial crop is rubber and is second only to
rice in cultivation.
• Other Crops cultivated include maize, cassava, sweet potatoes, ground nuts ,
soybeans, sesame seeds, dry beans, groundnuts and coconuts
35. Cambodia—Agriculture Overview
• The principal fruit crops: bananas, oranges, and mangoes, and are
supplemented by a variety of other tropical fruits like breadfruits,
mangosteens,and papayas.
• Cambodian agriculture is undergoing transformation with use of new
technologies, mechanization, productive use of labour etc.
• Cambodia’s agricultural production in the past grew mainly due to higher
paddy rice production, along with increase in production of maize cassava,
sugarcane, and vegetables.
• On the basis of profitability Vegetables were at the number one position in
Cambodia followed by cassava, maize, dry and wet season rice.
36. Cambodia—Agrochemical Overview
• No pesticides are manufactured in Cambodia and are imported from
neighbouring countries through legal or illegal means.
• According to an FAO publication the widely used category of pesticide in
Cambodia are insecticides
• Major pesticide used in Cambodia are paraquat, glyphosate, metolachlor,
quizalafop, and etc.
• Tricyclazole and pesticides in Group I of GHS table are banned in Cambodia
37. Cambodia—Registration of pesticides
Registering authority
Ministry of Agriculture, Forestryand Fisheries
Eligible applicants
A natural or a legal citizen of Cambodia
Pesticides need Registration
Pesticides to be traded, formulated or imported in Cambodia
38. Cambodia—Registration requirements
• The standard requirements for pesticide registration shall include
information and data on :
• Identity of the applicant
• Identity of the pesticide and its formulating process;
• Data on product specification, compositionsof active ingredients and finished product
• Physical and chemical properties of active ingredients and other data of pesticide
• Analytical method
• Data on bio-efficacy from country of origin as well as the local reports.
• Data on toxicity;
• Data on residue;
• Safety to human, animal, and environment;
• Reports on quality, adverse effects if any.
• Directions for use and safe disposal;
• Package and label in Khmer.
39. Cambodia—Registration requirements
• A registration may be denied if
• Information and data submitted with the application are false;
• Pesticide is highly toxic to public and environment
• Pesticide is found to be phytotoxic
• Efficacy of pesticide is lower than what is claimed
• Pesticide is persistent and remain in crops and the environment
• The certificate of registration is valid for 3 years after the date of issuance of the
certificate, except for the revocation before expiration.
• household pesticides and public health pesticides registration shall be jointly decided
by the Ministry of Agriculture, Forestryand Fisheries and the Ministry of Health.
40. Summary
In order to sell or distribute plant protection products(PPP)in Southeast
Asian Countries knowing your registration obligation is crucial.
Prepare in advance to not to disrupt your trade with Southeast Asian
Countries.
Auxilife can help you comply with those regulations. For more information
please contact us
41. • Development of regulatory strategy and
technical assistance to overcome regulatory
challenges including project strategy and
scoping
• Identification of compliance requirements
under various guidelines including all the
data requirements
• Data gap analysis and pre-assessment
support
• Technical documentation support
• Preparation of data waivers and bridging
arguments
• Study placement, monitoring, and design
• Pre and Post submission support and
technical liaison with authorities
How can Auxilife help you?